Navigating the complexities of regulatory compliance with data-driven Structured Content Authoring

  • Presentation
  • The Role of Technology in Compliance
  • 13. March
  • 11:50 - 12:30 AM (CET)
  • Meeting Room 5
  •  André Schlotz

    André Schlotz

    • RWS Group

Contents

Regulatory requirements are increasing across industries. Especially for Pharma and Medical Devices incomplete submissions, content inconsistencies and lack of cohesive structure of regulatory documentation are the most common reasons for market approval delays.

This presentation will explore

  • how data-driven and collaborative Structured Content Authoring (SCA) based on flexible template management drives reuse, ensures consistency across required documentation types and avoids delays in documentation reviews and regulatory approvals.
  • how the integration of external data sources with component content management enables the automation of partial document creation from templates to
    • streamline authoring and review workflows
    • reduce manual effort, increasing efficiency and productivity
    • minimize errors by sourcing data directly from the appropriate sources
    • dynamically adapt document content and structure based on the data received

Takeaways

Participants will learn techniques of working more integrative with data and reusable content components to make content authoring, management and delivery more efficient, compliant and accurate.

Prior knowledge

Basic Knowledge of CCMS and typical technical documentation processes

Speaker

 André Schlotz

André Schlotz

  • RWS Group
Biography

André Schlotz was holding various management positions in manufacturing and ICT companies for product development, aftersales, process organization and IT applications before joining RWS in 2013. At RWS, he helps companies to digitalize their content supply chain.